Telemonitoring and/or self-monitoring of blood pressure in hypertension (TASMINH4): protocol for a randomised controlled trial.

BACKGROUND: Self-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone. METHODS/DESIGN: This will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, lifestyle behaviours, health-related quality of life, and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension. DISCUSSION: The results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK. TRIAL REGISTRATION: ISRCTN 83571366 . Registered 17 July 2014.The trial is funded by an NIHR Programme grant, and by an NIHR Professorship awarded to Prof RJ McManus, the Chief Investigator. Omron have provided the blood pressure self-monitoring equipment via an unrestricted grant. Service support costs are administered through the NIHR Clinical Research Network: West Midlands. Professors Hobbs and Professor Farmer are NIHR Senior Investigators. This article presents independent research commissioned by the National Institute for Health Research (NIHR) under a Programme Grant for Applied Research (RP-PG-1209-10051)

Exercise response in Parkinson’s Disease : insights from a cross-sectional comparison with sedentary controls and a per protocol analysis of a randomised controlled trial

Objectives: To investigate the acute and adaptation cardiovascular and metabolic training responses in people with Parkinson’s (pwP). Design: 1) A cross sectional study of exercise response of pwP compared to sedentary controls,2) an interventional study of exercise training in pwP. Setting: Community leisure facilities. Participants: pwP (n=83) & sedentary controls (n=55) Interventions: Study (1) included participants from a two arm parallel single blind phase II Randomised Controlled Trial (RCT), that undertook a baseline maximal incremental exercise test and study (2) included those randomised to the exercise group in the RCT, who completed a six-month weekly exercise programme (n=37). The intervention (study (2) was a prescribed exercise program consisting of sessions lasting 60 minutes, twice a week over a six-month period. The control group followed the same protocol which derived the same cardio respiratory parameters, except the they were instructed to aim for a cadence of ~60rpm and the unloaded phase lasted 3minutes with an initial step of 25watts. Primary and secondary outcome measures: Stepwise incremental exercise test to volitional exhaustion was the primary outcome measure. Results: Study (1) showed higher maximum values for heart rate, VO2l.min-1, VCO2l.min-1 and Ventilation l.min-1 for the control group; Respiratory Exchange Ratio (RER), perceived exertion and O2 Pulse (VO2l.min-1/ HR) did not differ between groups. In study (2), for pwP who adhered to training (n=37), RER increased significantly and although there was no significant change in aerobic capacity or heart rate response, reduced blood pressure was found. Conclusions: An abnormal cardiovascular response to exercise was observed in pwP compared to controls. After the exercise programme, metabolic deficiencies remained for pwP. These observations add to the pathogenic understanding of PD, acknowledge an underling metabolic contribution and support that certain cardiovascular symptoms may improve as a result of this type of exercise Trial registration: ClinicalTrials.Gov (NCT01439022)

Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149.This work is funded from a National Institute for Health Research (NIHR) Programme grant for applied research (RP-PG- 1209-10051) and an NIHR Professorship awarded to RJM (NIHR-RP- R2- 12-015). RJM and KLT receive funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust. JS is a National Institute for Health Research (NIHR) Senior Investigator and supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South London (NIHR CLAHRC South London) at King’s College Hospital NHS Foundation Trust. Service support costs will be administered through the NIHR Clinical Research Network

Evaluation of low-dose aspirin in the prevention of recurrent spontaneous preterm labour (the APRIL study) : A multicentre, randomised, double-blinded, placebo-controlled trial

Funding: MdB, LV, TN, BM, MO and CdG received funding from ZonMw, The Dutch Organisation for Health Research and Development (grant number 836041006). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.Peer reviewedPublisher PD

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

Contains fulltext : 109349.pdf (publisher's version ) (Open Access)ABSTRACT: BACKGROUND: Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. METHODS/DESIGN: The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia.Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief.Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity), mode of delivery and maternal and neonatal side effects.The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. DISCUSSION: This study, considering cost effectiveness of remifentanil as first choice analgesia versus epidural analgesia, could strongly improve the care for 180.000 women, giving birth in the Netherlands yearly by giving them access to pain relief during labour, 24 hours a day. TRIAL REGISTRATION NUMBER: Dutch Trial Register NTR2551, http://www.trialregister.nl

“Double awareness”—adolescents and young adults coping with an uncertain or poor cancer prognosis: A qualitative study

IntroductionAdolescents and young adults with an uncertain or poor cancer prognosis (UPCP) are confronted with ongoing and unique age-specific challenges, which forms an enormous burden. To date, little is known about the way AYAs living with a UPCP cope with their situation. Therefore, this study explores how AYAs with a UPCP cope with the daily challenges of their disease.MethodWe conducted semi-structured in-depth interviews among AYAs with a UPCP. Patients of the three AYA subgroups were interviewed (traditional survivors, new survivors, low-grade glioma survivors), since we expected different coping strategies among these subgroups. Interviews were analyzed using elements of the Grounded Theory by Corbin and Strauss. AYA patients were actively involved as research partners.ResultsIn total 46 AYAs with UPCP participated, they were on average 33.4 years old (age range 23–44) and most of them were woman (63%). Most common tumor types were low-grade gliomas (16), sarcomas (7), breast cancers (6) and lung cancers (6). We identified seven coping strategies in order to reduce the suffering from the experienced challenges: (1) minimizing impact of cancer, (2) taking and seeking control, (3) coming to terms, (4) being positive, (5) seeking and receiving support, (6) carpe diem and (7) being consciously alive.ConclusionThis study found seven coping strategies around the concept of ‘double awareness’ and showcases that AYAs are able to actively cope with their disease but prefer to actively choose life over illness. The findings call for CALM therapy and informal AYA support meetings to support this group to cope well with their disease

Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial

Background Self-monitoring of blood pressure is common but how telemonitoring with a mobile healthcare (mHealth) solution in the management of hypertension can be implemented by patients and healthcare professionals (HCPs) is currently unclear.Aim Evaluation of facilitators and barriers to self- and telemonitoring interventions for hypertension within the Telemonitoring and Self-monitoring in Hypertension (TASMINH4) trial.Design and setting An embedded process evaluation of the TASMINH4 randomised controlled trial (RCT), in the West Midlands, in UK primary care, conducted between March 2015 and September 2016.Method A total of 40 participants comprising 23 patients were randomised to one of two arms: mHealth (self-monitoring by free text/short message service SMS) and self-monitoring without mHealth (self-monitoring using paper diaries). There were also15 healthcare professionals (HCPs) and two patient caregivers.Results Four key implementation priority areas concerned: acceptability of self- and telemonitoring to patients and HCPs; managing data; communication; and integrating self-monitoring into hypertension management (structured care). Structured home monitoring engaged and empowered patients to self-monitor regardless of the use of mHealth, whereas telemonitoring potentially facilitated more rapid communication between HCPs and patients. Paper-based recording integrated better into current workflows but required additional staff input.Conclusion Although telemonitoring by mHealth facilitates easier communication and convenience, the realities of current UK general practice meant that a paper-based approach to self-monitoring could be integrated into existing workflows with greater ease. Self-monitoring should be offered to all patients with hypertension. Telemonitoring appears to give additional benefits to practices over and above self-monitoring but both need to be offered to ensure generalisability

A long-term self-managed handwriting intervention for people with Parkinson's disease: results from the control group of a phase II randomized controlled trial

Objective: To report on the control group of a trial primarily designed to investigate exercise for improving mobility in people with Parkinson’s disease (pwP). The control group undertook a handwriting intervention to control for attention and time spent practising a specific activity. Design: Secondary analysis of a two-arm parallel phase II randomized controlled trial with blind assessment. Setting: Community. Participants: PwP able to walk ≥100 m and with no contraindication to exercise were recruited from the Thames Valley, UK, and randomized (1:1) to exercise or handwriting, via a concealed computer-generated list. Intervention: Handwriting was undertaken at home and exercise in community facilities; both were delivered through workbooks with monthly support visits and involved practice for 1 hour, twice weekly, over a period of six months. Main measures: Handwriting was assessed, at baseline, 3, 6 and 12 months, using a pangram giving writing speed, amplitude (area) and progressive reduction in amplitude (ratio). The Movement Disorder Society (MDS)–Unified Parkinson’s Disease Rating Scale (UPDRS) item 2.7 measured self-reported handwriting deficits. Results: In all, 105 pwP were recruited (analysed: n = 51 handwriting, n = 54 exercise). A total of 40 pwP adhered to the handwriting programme, most completing ≥1 session/week. Moderate effects were found for amplitude (total area: d = 0.32; 95% confidence interval (CI): −0.11 to 0.7; P = 0.13) in favour of handwriting over a period of 12 months; effects for writing speed and ratio parameters were small ≤0.11. Self-reported handwriting difficulties also favoured handwriting (UPDRS 2.7: odds ratio (OR) = 0.55; 95% CI: 0.34 to 0.91; P = 0.02). No adverse effects were reported. Conclusion: PwP generally adhere to self-directed home handwriting which may provide benefit with minimal risk. Encouraging effects were found in writing amplitude and, moreover, perceived ability

Cost-Effectiveness of Telemonitoring and Self-Monitoring of Blood Pressure for Antihypertensive Titration in Primary Care (TASMINH4).

The use of self-monitoring of blood pressure, with or without telemonitoring, to guide therapy decisions by physicians for patients with hypertension has been recently demonstrated to reduce blood pressure compared with using clinic monitoring (usual care). However, both the cost-effectiveness of these strategies compared with usual care, and whether the additional benefit of telemonitoring compared with self-monitoring alone could be considered value for money, are unknown. This study assessed the cost-effectiveness of physician titration of antihypertensive medication using self-monitored blood pressure, with or without telemonitoring, to make hypertension treatment decisions in primary care compared with usual care. A Markov patient-level simulation model was developed taking a UK Health Service/Personal Social Services perspective. The model adopted a lifetime time horizon with 6-month time cycles. At a willingness to pay of £20 000 per quality-adjusted life year, self-monitoring plus telemonitoring was the most cost-effective strategy (£17 424 per quality-adjusted life year gained) compared with usual care or self-monitoring alone (posting the results to the physician). However, deterministic sensitivity analysis showed that self-monitoring alone became the most cost-effective option when changing key assumptions around long-term effectiveness and time horizon. Overall, probabilistic sensitivity analysis suggested that self-monitoring regardless of transmission modality was likely to be cost-effective compared with usual care (89% probability of cost-effectiveness at £20 000/quality-adjusted life year), with high uncertainty as to whether telemonitoring or self-monitoring alone was the most cost-effective option. Self-monitoring in clinical practice is cost-effective and likely to lead to reduced cardiovascular mortality and morbidity.This work was funded by the National Institute for Health Research (NIHR) via a Programme Grant (RP-PG-1209–10051). RJMcM held an NIHR Professorship and leads the self-management theme of the NIHR Oxford Collaboration for Leadership in Applied Research in Health and Care (CLAHRC). FDRH acknowledges part support from the NIHR School for Primary Care Research (SPCR), the NIHR Oxford CLARHC, and the NIHR Biomedical Research Centre (BRC), Oxford. The views and opinions expressed are those of the authors and do not necessarily reflect those of the NHS, NIHR, or the Department of Health and Social Care

"Double awareness"-adolescents and young adults coping with an uncertain or poor cancer prognosis:A qualitative study

INTRODUCTION: Adolescents and young adults with an uncertain or poor cancer prognosis (UPCP) are confronted with ongoing and unique age-specific challenges, which forms an enormous burden. To date, little is known about the way AYAs living with a UPCP cope with their situation. Therefore, this study explores how AYAs with a UPCP cope with the daily challenges of their disease. METHOD: We conducted semi-structured in-depth interviews among AYAs with a UPCP. Patients of the three AYA subgroups were interviewed (traditional survivors, new survivors, low-grade glioma survivors), since we expected different coping strategies among these subgroups. Interviews were analyzed using elements of the Grounded Theory by Corbin and Strauss. AYA patients were actively involved as research partners. RESULTS: In total 46 AYAs with UPCP participated, they were on average 33.4 years old (age range 23-44) and most of them were woman (63%). Most common tumor types were low-grade gliomas (16), sarcomas (7), breast cancers (6) and lung cancers (6). We identified seven coping strategies in order to reduce the suffering from the experienced challenges: (1) minimizing impact of cancer, (2) taking and seeking control, (3) coming to terms, (4) being positive, (5) seeking and receiving support, (6) carpe diem and (7) being consciously alive. CONCLUSION: This study found seven coping strategies around the concept of 'double awareness' and showcases that AYAs are able to actively cope with their disease but prefer to actively choose life over illness. The findings call for CALM therapy and informal AYA support meetings to support this group to cope well with their disease